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临床试验/NCT03987178
NCT03987178已完成不适用

Microbiologic Alterations of the Conjunctiva of Hot Tub-soaking Ophthalmologists

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Quantity of organisms

研究概览

简要总结

The purpose of this study is to determine if there are microbiologic alterations of the ocular surface after hot tub exposure. The study will evaluate the number of microbes before and after hot tub use in order to find out whether hot tub exposure has any change on the organisms present on the ocular surface. Participants will be randomized to dunk or not to dunk their head during their time in the hot tub.

详细描述

Keratitis is a rare destructive cause of blindness. It typically affects young and healthy individuals, is excruciatingly painful, and difficult to treat. With 60% of cases mis-diagnosed at presentation, acanthamoeba keratitis carries a far worse visual prognosis compared to other cornea infections. Exposure to hot tubs is a widely accepted risk factor. However, the mechanism of infection and prediction of who is at risk is unknown as the vast majority of hot tub users do not become infected.In vivo changes to ocular microbiology after hot tub exposure has never been described.

Changes to ocular microbiology after exposure to hot tubs have not been described. The purpose of this study is to investigate whether there are significant alterations in the microbiology of the conjunctiva after hot tub exposure that may contribute to these changes.

This study will recruit at least 34 subjects, who will be randomized to head submersion versus no head submersion, using at least three different hot tubs. A conjunctival swab, a minimal-risk test performed routinely in the eye clinic, will be performed before and after 15 minutes of hot tub exposure on one eye (randomized) per subject. The swabs will be plated on blood agar (bacterial cultures) and non-nutrient agar (acanthamoeba cultures).

In this prospective study, healthy subjects will be recruited. The study will be Health Insurance Portability and Accountability Act compliant and approved by the Institutional Review Board. All subjects will review and sign an informed consent form.

Each patient will have the conjunctiva of one eye (randomized) cultured. This practically no-risk technique entails touching a polyester-tip swab to the lining of the lower eyelid. Each subject will be randomized to head submersion or no head submersion; this exposure will be masked by the study coordinator. After 15 minutes of hot tub exposure, the subject will have the same eye swabbed for cultures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

A provider is assigned to perform conjunctival swabs; this person is completely masked to exposure. The culture plates, which are randomized, are sent to a microbiology lab and the technicians are completely masked to exposures when reading the plates.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Quantity of organisms

时间窗: 1 year

Genus-species will be identified for each sample, and quantified with an ordinal scale (0-4). The total of this score will be the quantity for that person-time. The primary analyses will be a Wilcoxon Rank Sum test (Mann-Whitney) between the two arms at the follow-up time point (randomized comparison of dunk vs no-dunk), and a Wilcoxon Signed Rank test between pre-hot-tub and post-hot-tub (longitudinal comparison of all cases). We estimate that a total of 20 subjects will provide 80% power to detect a 1.25 SD difference in the total quantity score between randomization arms at the post (f/u) time point. We estimate 80% power to detect a .9 SD difference between pre (baseline) and post (f/u) time points in a paired longitudinal analysis.

次要结局

  • Richness (number of species per sample) of organisms found in the conjunctiva with hot tub use (post-test comparison)(1 year)
  • Richness (number of species per sample) of organisms found in the conjunctiva with hot tub use (pre versus post)(1 year)
  • Difference in organism profile with hot tub use (between arms)(1 year)
  • Specific organisms found in the conjunctiva with hot tub use(1 year)
  • Difference in organism profile with hot tub use (pre versus post)(1 year)
  • Quantity comparing pre-hot tub and post-hot tub swabs(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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